The drugmaker is on what it calls a transparency kick. Having already created registries listingclinical trials and grants, Lilly is apparently the first big drugmaker to back the Physicians Payments Sunshine Act, which would establish a national registry of payments to docs by drug and device makers. Although this is a revised version (see below).
Drug and device makers have been under pressure to take such steps. You may recall a dozen drug and device makers last month told Chuck Grassley, the Iowa Republican and a co-sponsor of the bill, that they would publicly disclose grants to outside groups, and the details will be provided on each company’s web site. And as part of a settlement with the Department of Justice, five device makers agreed to post consultant payments on their web sites.
In a statement, Herb Kohl, a Wisconsin Democrat and the other co-sponsor of the bill, praised Lilly. “Eli Lilly’s endorsement goes to show that transparency of the financial ties between doctors and drug makers is not only sensible, but do-able," he says.
UPDATE: We belatedly note two revisions that water down the original bill. Companies must publicly report gifts over $500; originally, that was $25. And fines were reduced to between $1,000 and $50,000 for each violation. The earlier proposal set fine at $10,000 to $100,000 per violation. Nothing like a compromise to gain support.
"Lilly...believes this legislation represents an important step in building public trust and confidence in the relationships between the pharmaceutical and device industries and physicians," John Lechleiter, Lilly's newly promoted ceo, in a statement. "This will help provide the assurance that Lilly runs its business consistent not only with our principles, but with the principles that a healthcare provider or patient should expect from a pharmaceutical company."
Lilly, however, has stopped short of full disclosure in some cases. Its grant registry doesn't contain any listings before 2007. And as we noted last October, its clinical trial registry doesn't list Phase IV trials completed before July 1, 2004. And while the Cialis web site boasts about safety and effectiveness in 22 trials, not all show up on the Lilly trial registry. You can read about that here.
11 Comments
Way to go Lilly! That's great news. I hope that my employer and other big pharma companies follow suit. Full disclosure of clinical trial data and of physician payouts -- great news for everyone. I hope that this is the beginning of salvaging our industry's tattered reputation.
Agreed. Would love to see my company support this but what I hear instead is that we are fighting it like crazy behind the scenes. Very disappointing. If our payments to physicians for speaking and consulting cannot be defended then we probably shouldn't be doing it. But rather than participate in necessary change we will fight and fight until we are pulled into it with our last gasping breath. Again, what we lack is leadership. I never would have expected it to be Lilly to take a leadership position like that but the industry certainly needs it. I think Lilly might just be trying to get out in front because they will probably be announcing a huge settlement with the government. But there's nothing wrong with a turn-around as long as the new direction is the right one. We certainly can't expect leadership from Merck, Schering, BMS, Novartis, Pfizer or Sanofi/Aventis.
It's very heartening to hear these responses. They don't surprise me, but it's good to hear directly. Thanks for that!
I think everyone will jump on board now, they have no choice; who wants to stick out with a big bullseye?
Good for Lilly to being the first. I et all the other big ones are kicking themselves for being too slow.
I also think that this is a good thing. Sounds like there was some coming together of minds to do something that everyone can live with and bring some reason to this stupid debate.
Can this be an example of things to come?
Give me a break! The company that used piles of money to sell Zyprexa to thousands of people that didn't need it. The same company that used oodles of cash to push Prozac for years. Too little too late. They won't be able to weasel their way out of the Zyprexa mess!
Skeptical,
I get your point, what do you want? We keep criticizing companies and demanding things from them. When they do them or give them to us we still want to shoot them down.
How can we ever get beyond this. If in your mind it is a lost cause then don't waste your time blogging or your nerves worrying about it. On the other hand, there are enough of us in these blogs who see that there is a way forward.
Self-regulation doesn't tend to be very efficient regulation, on the whole - we still don't have access to negative trials' data, after all, whatever one's position on that may be. There's a culture, here, that is anything but transparent. Can an opaque culture conduct a transparent act, in a transparent way? I'm not sure that it can.
Incidentally, it always amuses me greatly to point out that Eli is the company that made LSD for the CIA's Mind Control programme. To what extent does Eli still think like that?
Matt
It wouldn't surprise me at all to find out that even though Lilly backs this bill publicly, behind the scenes they are paying off politicians and everyone else in their way to keep it from getting past.
This stance is great PR for the company, but ultimately it would only hinder their company goals and affect their profits.
I don't believe lilly or any other big Pharma company would honestly support this type of legislation.
Tim -- While I continue to applaud Lilly's decision, I completely agree with your cynisism. This goes back to a discussion we were having a couple weeks ago. Companies frequently face choices between profit and ethics. Which will they choose? Unless there is a big stick or a big carrot, they will choose profit. Therefore, I can only assume that one of the following is true: 1) They figured that these laws were coming anyway, so they might as well look like the "good guy" and jump on board early. 2) They really were beginning to feel financial pressure from lawsuits, shareholder demands, fines, etc. 3) They really took a "long-term" view of the industry and figured that continuing down the current path would lead to long-term lower valuation of our industry (due to #2). 4) I was wrong about the “big stick/big carrot” approach and Lilly execs really do put ethics before profits.
Good attempt at positive PR, but probably will not fundamentally change the way they do business. They have been on the edge too long. That's probably why they won't reveal the past activities. It would be too much of a risk. The Big Pharma companies are all about trying to build trust at this point, but they have a long, long way to go. Too many misdeeds over too many years to rake in too much money. Who's going to make sure that they've really turned obver a new leaf? We can't yet trust them to.
Nathan,
I agree with your assessment here, and I too commend Lilly on this move whatever their motive - assuming that it is not to water the bill down so the risk analysis makes it easier to go ahead and do whatever they want. I think it may simply be an issue where one law is better than fifty.
I have to wonder about the term "gifts" and what will constitute "payments" though. If a company pays for "consultation" work is that a gift or compensation? I would assume a plane ticket to a conference would be a gift, but what about payments to a practice to defray research project expenses for those undisclosed Phase IV trials? There is a lot that can be done to a bill to dilute it's intent beyond what is reported here.
Let us not forget that Lilly has an aggressive stance public policy even down to the state level. In several states, Lilly has sponsored and passed legislation which limits public and private payors ability to ensure appropriate use of the medications they produce. These have been promoted as "open access" laws, but the actual intent is to prohibit Drug Utilization Review activities, step therapy (which if you believe the STAR-D results, may be entirely reasonable for antidepressants), or any need for prior approval or review on everything from ADD medications to atypical antipsychotics (even in children or institutionalized frail elderly - where there should be more caution).
Lilly also infiltrated and ran the National Alliance for Mental Illness for a number of years. On cafepharma, even their own reps call the company "We Lie" Lilly. Poor Eli, he left a fine legacy for a long time. Not so much anymore.